Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

Novartis Vaccines72 enrolled

Overview

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Influenza

Interventions

Adjuvanted Influenza VaccineBIOLOGICAL

1 dose of Adjuvanted Influenza Vaccine

Influenza VaccineBIOLOGICAL

1 dose of Influenza Vaccine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment Exclusion Criteria: * serious medical conditions * allergies to vaccine components, including but not limited to egg/chicken products * reduced immune function * recent use of immunosuppressive therapy * recent use of influenza vaccine

Locations (1)

I.P.A.S.

Ligornetto, Switzerland

Outcomes

Primary Outcomes

Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers.

Time frame: 36 Days

Secondary Outcomes

To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine

Time frame: 36 Days

Data from ClinicalTrials.gov

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